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Medical Expulsive Therapy for Ureter Stone Using Naftopidil

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Seoul National University

Status and phase

Completed
Phase 3

Conditions

Ureter Stones

Treatments

Drug: Placebo for Naftopidil
Drug: Naftopidil 75mg
Drug: Standard treatment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01952314
SNUBH-URO-2012-03
SNUBH-URO-2012-03-MET (Other Identifier)

Details and patient eligibility

About

This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

Full description

  1. Enrollment

    1. patients with ureteral stones of sizes from 3 to 10 mm
    2. patients aged more than 18 years
  2. Randomization

    1. naftopidil 75 mg qd for 14 days or placebo
    2. Standard treatment with pain-killers were also applied.(aceclofenac)
  3. Follow-up for 28 days

    1. We confirm the stone free status by CT or X-ray films at 14th and 28th days.
    2. Rates of active treatment will be also evaluated.

Enrollment

150 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >= 20 years
  • single 3 to 10 mm ureter stone (longest diameter)

Exclusion criteria

  • Presence of multiple ureter stones
  • Renal insufficiency (serum Cr > 1.4 mg/dL)
  • Febrile urinary tract infections(fever > 38°C, evidence of urinary infection)
  • pregnancy or breast feeding
  • solitary kidney
  • hypersensitivity to naftopidil
  • current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)
  • moderate or severe cardiovascular or cerebrovascular disease
  • hepatic dysfunction (>2 x normal upper limit)
  • significant active medical illness which in the opinion of the investigator would preclude protocol treatment
  • Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups, including a placebo group

Control groups with only analgesics
Placebo Comparator group
Description:
Control groups will receive only analgesics.
Treatment:
Drug: Standard treatment
Drug: Placebo for Naftopidil
Naftopidil
Active Comparator group
Description:
This interventional group will receive analgesics and naftopidil 75mg po qd.
Treatment:
Drug: Standard treatment
Drug: Naftopidil 75mg

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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